Now, moving along to registration. This is the article 29 obligation from the MDR, and the article 26 from the IVDR. The BUDI is a data element that has gotten a lot of attention and has created some anxiety along the way, and without getting into too much detail, the BUDI, like the UDI, is a package of attributes and data. Both will have places that they will be used in common, for instance, the regulatory submissions shown here, each will have unique places where the information is displayed. So for instance, your BUDI will be found on declarations of conformity and on summaries of safety and clinical performance. While a UDI is the type of data you find on primary product labels, implant cards and vigilance communication.
Graphically, we have a UDI which is broken up into two parts, it essentially contains the UDI-DI: the device identifier, and the UDI-PI: the product identifier, and these will be provided for reporting serious incidents and Field Safety Corrective Actions (FSCA), which will be provided to patients receiving implants under the MDR.
The economic operators in your supply chain are going to be obliged to maintain electronic records of the BUDI for class III and implantable devices, as well as devices that will be detailed in any implementing act yet to be published. This is an obligation of the economic operators that is reflected as well. With health institutions throughout the EU, they will also be compelled to maintain BUDI records for all class III and implantables, as well as devices detailed in the implementing act. There is an element of the unknown here in the respect that member states, as stakeholders, may encourage or require healthcare institutions to maintain records of BUDIs for all devices.
This is an area to watch closely because it would be an increase in the amount of effort necessary to be compliant with regulations for registration. We are waiting to see where the various different jurisdictions land on this, and I encourage you to stay in touch with Celegence, who will help keep you notified and help you navigate through the unknown with respect to this type of jurisdiction specific requirement that may be emerging over the next many months.
Now for those of you interested in marketing in the UK, including Britain, Scotland and Northern Ireland, the MHRA has issued requirements for products of all classes to be registered with the UK as well, and this is going to be necessary for those who don’t have an alternate means of completing it by the end of the year 2020. The grace periods for class III and class II devices have already passed, and the period for the class I devices will pass at the end of December. This legal requirement to register will not affect you if you have an existing relationship with an authorized representative within the UK. Be aware, however, that this is guidance that is based on the concept of a hard Brexit at the end of December of 2020, and as December 31st approaches, things may change as there may be a trade agreement. The MHRA may provide additional further guidance, suffice it to say, this is an area that is being closely watched as well, and as such, Celegence can help keep you up to date on the requirements as they become public.
I would like to move on to product types of immediate concern. Specifically, products that will be marketed on directive certificates after the date of applicability in the EU will be regarded as legacy devices. The MDR does not specifically require BUDIs on legacy devices, but the EU commission has essentially detailed a two-part work around.
First, registration will be necessary according to the article 29 requirements, but it will be possible to complete that registration in the absence of a BUDI using other attribute data and including your UDI. Moving forward with that approach, legal manufacturers will bear a certain amount of risk. In that respect, if there is a Field Safety Corrective Action (FSCA) that occurs with such a legacy device, and it has not been registered by its BUDI, the effective device must be then immediately registered now for the reporting of the serious incident or FSCA.
To me, it looks like the European commission is preparing an on-demand system to handle such events, even before the registration system is available on a broader basis for legacy devices.